MAUDE Adverse Event Report: ARTHREX, INC. ARTHREX ANGEL PRP KIT (US TRAY); PLATELET AND PLASMA SEPARATOR

Model Number	ARTHREX ANGEL PRP KIT (US TRAY)
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 08/12/2025, a sales representative reported via (b)(4) that an abs-10060 angel centrifuge kept giving an insufficient fill error - there was plenty of blood in the machine.This occurred during an ankle fusion with prp for the bone graft; they ended up having to abort the procedure, and the disk was stuck in the machine afterward.They had several people try to get the disk out with no luck.We were able to finish the case, but did not end up using prp to mix with bone graft; the doctor pulled whole blood instead.Additional information was provided on 08/19/2025 via phone, where it was confirmed that the procedure itself was not aborted; however, the prp portion of it was.They continued the case by redrawing blood and mixing it with the bone graft.The disc that became stuck was an abs-10061t.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint allegation is confirmed by the attached pictures.The angel set and angel prp system were stuck.Also, they showed blood around the tubing, bag, and disk of the angel set and blood drainage from the disk/tubing into the rotor housing of the angel prpsystem.Based on the information provided, which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to user error of the device due to the misalignment of insertion/and or improper seating of the angel processing set.

• Brand Name: ARTHREX ANGEL PRP KIT (US TRAY)
• Common Device Name: PLATELET AND PLASMA SEPARATOR
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 22940442
• Report Number: 1220246-2025-03698
• Device Sequence Number: 9755329
• Product Code: ORG
• UDI-Device Identifier: 00888867279919
• UDI-Public: 00888867279919
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: BK180180
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: ARTHREX ANGEL PRP KIT (US TRAY)
• Device Catalogue Number: ABS-10061T
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2025
• Supplement Date Received by Manufacturer: 09/26/2025
• Initial Report FDA Received Date: 09/02/2025
• Supplement Report FDA Received Date: 09/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown